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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K844556
Device Name KHM 2000 DRIP WATCHER
Applicant
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Applicant Contact TERRY L LANDIS
Correspondent
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Correspondent Contact TERRY L LANDIS
Regulation Number880.2420
Classification Product Code
FLN  
Date Received11/21/1984
Decision Date 01/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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